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Approval Sought for Over-the-Counter Birth Control

photo of birth control pills

July 11, 2022 -- A drug maker is seeking government permission to become the first company to sell over-the-counter birth control pills in the United States.

HRA Pharma has filed an application with the U.S. Food and Drug Administration to sell its birth control pill called Opill without a doctor’s prescription, the company said in a news release.

The French-based company expects an FDA decision in about 10 months, The New York Times reported. Reproductive rights have become a national issue since the recent U.S. Supreme Court decision that overturned Roe v. Wade, but HRA Pharma says its application is not related to that court ruling, The Times said.

"This historic application marks a groundbreaking moment in contraceptive access and reproductive equity in the U.S.," said Frédérique Welgryn, chief strategic operations and innovation officer at HRA Pharma. "More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant. Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."

In the U.S., medical professionals prescribe birth control pills and in doing so are supposed to check for the risk of rare but dangerous blood clots, The Associated Press reported. HRA Pharma’s application contains research showing women can screen themselves for those risks, the AP said.

Opill is called a mini pill because it contains only one synthetic hormone, progestin. Most birth control pills sold in the United States are “combination pills” that include estrogen, which can make periods more regular but accounts for most of the blood clot risk in birth control pills, The AP said. The New York Times said minipills make up about 10% of the U.S. birth control pill market.

FDA data shows that among 10,000 women taking combination pills yearly, only three to nine will suffer a clot, the AP said. In comparison, blood clots will occur in one to five women among 10,000 not taking birth control pills.

Birth control pills can already be purchased without a doctor’s prescription in much of South American, Asia, and Africa, AP said. In the United Kingdom, HRA Pharma gained approval last year to sell a birth control pill without a prescription.

In the United States, medical groups such as the American Medical Association and the American Academy of Obstetricians have favored OTC birth control pills for years, along with numerous women’s rights groups.

The FDA has come under criticism from conservative groups for expanding access to birth control with products like the emergency contraception pill Plan B. Late last year, the FDA made permanent access to so-called abortion pills by mail.

Show Sources

PRnewswrite. “Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill”

The New York Times. “F.D.A. to Weigh Over-the-Counter Sale of Contraceptive Pills”

The Associated Press. “Over-the-counter birth control? Drugmaker seeks FDA approval”

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